Pharmacy Practice: Controlled Substances

Controlled Substances

• A drug or substance tightly controlled by the government due to its potential for abuse or addiction.
• Control applies to its manufacture, use, handling, storage, and distribution.
• Examples include opioids, stimulants, depressants, hallucinogens, and anabolic steroids.

Regulation of Controlled Substances

• Laws: DRAP Act, 2012, Drugs Act, 1976, and Control of Narcotic Substances (CNS) Act, 1997.
• Division of controlled drugs: DRAP in consultation with the Ministry of Narcotics Control is responsible for regulation and allocation of quota of narcotic drugs, psychotropic substances, and precursor chemicals.

Categories of Controlled Substances

• Narcotic Drugs
• Psychotropic Substances
• Precursor Chemicals

Distribution of Controlled Substances

• Fundamentals:
  • Securely stored and handled throughout the medication management system.
  • Accurate and complete records of all transactions maintained in a timely manner.
  • All manual documentation is made in indelible ink.
  • Clear chain of signatures showing transfer of responsibility at each transition point.
  • Records can be easily audited.
• Principles:
  • Quantities kept to the minimum needed according to patient population and degree of urgency.
  • Authorized staff handle, prescribe, or have access to controlled substances.
  • Stored in restricted areas, such as locked rooms, carts, or fridges.
  • All keys are accounted for at all times.
  • Systems set up to ensure each user is uniquely identified and every transaction can be traced.

Inventory Management

• Key principles:
  • Keeping stock secure at all times.
  • Maintaining accountability and sign-offs by authorized staff at all transition points.
  • Checking for completeness of an order and integrity of the product at all transition points.
• Consideration should be given to maintaining the lowest amount of inventory possible while ensuring reasonable and timely access.
• Factors to consider when determining drug needs:
  • Medical conditions being treated.
  • Local protocols, pathways, and care maps.
  • Drug formulary and formulary policies.
  • Utilization and prescribing patterns.
  • Range of dosing (e.g., pediatric vs adult care; acute vs chronic pain management).
  • Availability and capacity of secure storage.
  • Travel time between receiving department, pharmacy, care units, and other sites.

Procurement

• Licensed dealer (e.g., manufacturer or distributor) shall supply a hospital with a controlled substance.
• Manual Procurement Process:
  • Manual ordering should be minimized.
  • Forms used to purchase controlled substances should be sequentially prenumbered and closely controlled using a log.
  • Under no circumstances should blank purchase orders or requisitions for controlled substances be pre-signed or left unsecured.
• Electronic Procurement Process:
  • Only restricted to individual authorized users.
  • Should have unique access code to order controlled substances.

Storage

• Controlled substances maintained in the pharmacy department should be stored:
  • In a manner that ensures their physical security.
  • Adhering to the recommended storage conditions for the drug.
  • Meeting relevant standards (e.g., from accreditation or regulatory authorities).
• Access to controlled substances or areas where they are stored should be further limited to designated pharmacy staff.

Storage in Patient Care Areas

• Should use a double or triple lock procedure.
• The medication room door and the locked cupboard should never have the same lock.
• Alternatively, controlled substances may be stored in locked drawers in medication carts used to deliver the drugs to patients but it should never be left unattended.

Dispensing

• Each formulation and container type should have a separate record within the perpetual inventory.
• For each medication movement, the pharmacy record should include:
  • Date.
  • Time of issue.
  • Patient care area.
  • Drug name, strength, and dosage form.
  • Quantity delivered or returned.
  • Names and signatures of pharmacy and patient care area staff involved.

Model Set of Hospital Control Procedures

• Responsibility for controlled drug substances in hospital:
  • Administrator is responsible for the proper safeguarding and handling of controlled substances.
  • Pharmacist in chief is responsible for purchase, storage, accountability, and proper dispensing of controlled substances.
  • Registers must be maintained for dispensing of controlled substances.
• Ward stock for controlled substances:
  • Stock is replaced by duly signed sheet and provision of empty vials.
  • Each request for new supply is accompanied by a controlled drug administration form.
  • For any drug that is lost or wasted, the nurse in charge must prepare an incident form.

Doctor's Order for Administration of Controlled Drug

• Duly signed by physician in non-edible ink.
• Prescription can only be written by licensed and authorized physician or registered resident.

Miscellaneous Regulations

• Ward supplies of controlled medicines should only be used for patients on the ward.
• Narcotic prescriptions are not refilled.
• Prescription is retained for records.
• Physician may not prescribe narcotics for personal use.

Control of Narcotics by Nurses

• Narcotics are audited for count and use in every shift change.
• Every shift has a designated nurse for narcotics control.
• Both the nursing staff from new and old shift sign the records.
• If discrepancy found, it should be reported to the pharmacy.

Research Use

• Personnel involved in research are to be registered under DRAP rules.
• If there are more than one location, each location has to be registered separately.
• Each personnel has to keep records of research and controlled substance used, including:
  • Receipt records.
  • Dispensing records.
  • Administration records.

This quiz covers controlled substances, laws applicable to them, and their distribution and dispensing in hospital pharmacy practice. It is designed for PharmD students.